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The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product
Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.
Our experienced team of more than 700 pharmacovigilance professionals worldwide provide 24/7/365 availability and is fully focused on identifying and applying valuable insights based on pharmacovigilance needs.
Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine
PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.
The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and the set-up of a pharmacovigilance system.
We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.